A Phase II Study of Cabozantinib in Women with Hormone Receptor-Positive Breast Cancer that Spread to the Bone

Protocol

12-091

Full Title

A Phase II Trial of Cabozantinib in Women with Metastatic Hormone-Receptor-Positive Breast Cancer with Involvement of Bone

Phase

II

Purpose

Cabozantinib (XL184) is an investigational drug that blocks several proteins (called MET, RET, and vascular endothelial growth factor receptor 2) that help keep cancer cells alive. It is a capsule that is taken orally (by mouth). Cabozantinib has shown promise in other clinical trials where it has been evaluated for prostate cancer that has spread to the bones.

In this phase II study, researchers are evaluating the safety and effectiveness of cabozantinib in women with hormone receptor-positive breast cancer that has spread to the bones.

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have breast cancer that has spread to the bones and persists despite at least one prior regimen of chemotherapy or hormone therapy for metastatic disease.

Patients’ tumors must have estrogen and/or progesterone receptors and be negative for HER2.

Patients must have recovered from the serious side effects of prior therapies before entering the study.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Monica Fornier at 646-888-5240.